Artificial Intelligence and Software, you are very welcome to Great Britain

Recent events show that the UK is determined to provide its RA regime with an avant-garde design to perfectly fit and suit cutting-edge technologies, when applied to the medical devices industry. Last news in this regard is brought by the newly published programme on software and AI as Medical Devices, which deploys features aiming at delivering a high degree of protection for patients and the public, while securing the UK remains home of innovation within the industry. It is worth mentioning that, despite the EU MDR will not be transposed into UK national law, some of its enhanced safety elements are going to be mirrored in the upcoming UK MDR RA regime.

It is worth mentioning that, despite the EU MDR will not be transposed into UK national law, some of its enhanced safety elements are going to be mirrored in the upcoming UK MDR RA regime.[/vc_column_text]

For the readers’ convenience, we present below the main features of the AI/Software programme:

  1. The MHRA talks will spin around the concept of safety and assurance of the intended purpose of the devices at stake (Software and AI). Bluntly speaking, the benefit-risk ratio is to be guaranteed thereby protecting patients and the public;
  2. The need of making clear the requirements your software or AI needs to meet to be considered as a Medical Device. To this end, clarificatory guidelines will be drafted and issued, and standards will be set forth as the main tool to demonstrate RA compliance;
  1. Digital health is in the spotlight and the UK will be gathering key partners – such as NHSX and the National Institute for Health and Care excellence – to align requirements among the involved bodies, avoid duplication, and ultimately provide a joint-up offer for digital health within the Kingdom.

In turn, the programme includes 11 work packages across two workstreams:

The first stream is dedicated to key reforms across software as a medical device lifecycle. In this endeavour, the UK will deal with 8 work packages aimed at achieving three major objectives each:

1. Qualification

  • Ensure UK Medical Devices Regulations encompass software to the extent sufficient to protect patients and the public;
  • Ensure both clarity and flexibility when regulating software as a medical device;
  • Ensure cooperation among the involved actors regarding the regulation of digital health, even where software does not qualify as a medical device.

2. Classification

  • Ensure there is little room for interpretation in classification rules, so that the tracking of the risk that a specific medical device software (SaMD hereinafter) poses to patients is fairly controlled;
  • Ensure safety and performance requirements are proportionate to the risk of the device;
  • Ensure the flexibility of classification rules when dealing with novel devices in terms of risk assessment to properly understand the former.

3. Pre-market

  • Ensure quality, safety, and efficacy of the SaMD a priori;
  • Ensure the clarity of clinical evidence and investigation requirements;
  • Ensure that any premarket submission includes appropriate registration requirements to support a robust post-market surveillance system.

4. Post-market

  • Secure that PMS produces a strong and clear safety signal, allowing for quicker and thorough capture of adverse incidents;
  • Period Safety Update Report (PSUR) will be requested;
  • Articulate clear change management requirements and processes.

5. Cyber Secure Medical Devices

  • Link cybersecurity issues with SaMD safety issues;
  • Ensure cybersecurity is considered in the premarket and in post-market surveillance requirements;
  • Ensure cooperation among the relevant bodies.

6. Innovative Access

  • Explore the need for a novel pathway mid-way between the pathway to market for medical devices and the Innovative Licensing and Access Pathway (ILAP);
  • Should the previous be applicable, articulate it for medical devices on the basis of the threefold criteria developed by ILAP: critical need, innovation, and compelling benefit;
  • Likewise, pilot how such a route might be best implemented for digital health technologies.

7. SaMD Airlock

  • Explore whether there is a need for an ‘airlock classification rule’ that allows timely access to the market for novel and innovative SaMD whose risk profile needs to be further studied and monitored;
  • If there is a need, articulate the criteria to be eligible for this rule, how it might function, and when it would cease to apply;
  • Ensure that, if a SaMD Airlock rule is articulated, it dovetails with other pathways, fits other regulators’ processes, and does not substantially overlap with other classification rules.

8. Mobile Health, and Apps

  • Work across government and via other work packages to ensure that the mHealth SaMD market provides further safety, effectiveness, and quality assurance;
  • Effectively triage any existing safety or effectiveness concerns;
  • Develop methods to address such concerns, with the purpose of minimising the risk to the patient and the public.

Once the tasks of the first workstream are presented and clear, let’s proceed with the second one. The latter is linked to further challenges, which may be brought by the Artificial Intelligence, to the UK MDR. In this endeavour, 3 work packages, which operate in tandem with the previously exposed ones, have been set forth:

1. Project AI RIG (AI Rigour)

  • Utilise existing frameworks to ensure AI as medical devices (AIaMD) placed on the market are safe and effective;
  • Develop supplementary frameworks to enhance the above purpose;
  • Develop technical methods to enhance the testing of AI as a medical device, to improve safety and effectiveness.

 2. Project Glass Box (AI Interpretability)

  • Show how lack of RA transparency is not desirable for safety and generates issues;
  • Develop frameworks on the interpretability of AIaMD to ensure transparency;
  • Develop frameworks on usability and its safety and effectiveness features.

 3. Project Ship of Theseus (AI Adaptivity)

  • Articulate problems with medical device regulation for adaptive AIaMD, paying due attention to the specificities of each set;
  • Clarify how each type may fit within the existing change management processes required by medical device regulations;
  • Where appropriate, craft new rules and guidance allowing adaptive AIaMD that does not suit the existing change management processes.

We already know that most of the actions needed to achieve the abovementioned goals will come in the form of clarificatory guidance, processes and standards, and not through UK secondary legislation.

Nonetheless, in case of legislative change proposals stemming from any workstream, these will build upon wider reforms on medical device regulations, which are already underway.

Likewise, we expect to receive the key elements of each work package in the period oscillating between Autumn 2021 and Summer 2023. Conversely, consultation panels open to the public will be created shortly.

On an ending note, we kindly direct the reader to the very body of the article where they can find the FAQ on the matter.

Should you have any doubts about the UK RA regime, wish to place your goods therein, or simply seek guidance, do not hesitate to contact Obelis UK.

Should you have any doubts about the UK RA regime, wish to place your goods therein, or simply seek guidance, do not hesitate to contact Obelis UK.

Carlos Francisco Marín Barrios

Regulatory Affairs Department


Should you like to appoint Obelis UK as your UK RP, or if you simply need guidance on your UK documentation, please do not hesitate to contact us.

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  • UK., Software and AI as Medical Device Change Programme, published 16 September 2021. Available at Software and AI as a Medical Device Change Programme – GOV.UK ( Accessed on 21/09/2021.
  • UK., Consultation on the future regulation of medical devices in the United Kingdom, published 16 September 2021. Available at Consultation on the future regulation of medical devices in the United Kingdom – GOV.UK ( Accessed on 21/09/2021.

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